Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906664920036 Date of Approval: 10/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmeditomidine-ketamine sedation versus ketamine-midazolam sedation in pediatrics with surgically uncorrected TOF undergoing cardiac multi-slice spiral CT
Official scientific title Dexmeditomidine-ketamine sedation versus ketamine-midazolam sedation in pediatrics with surgically uncorrected TOF undergoing cardiac multi-slice spiral CT
Brief summary describing the background and objectives of the trial Procedural sedation may be preferred over general anesthesia as it provides an easier procedure for the clinician and more comfort for the patient for unpleasant diagnostic procedures.The aim of the study is to assess dexmedetomidine-ketamine sedation compared with ketamine- midazolam sedation for pediatric patients with uncorrected Fallot tetralogy (TOF) undergoing multi-slice spiral computed tomography (MSCT).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 18/03/2019
Actual trial start date 20/02/2019
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date 01/07/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine ketamine intravenous (IV) dexmedetomidine (1 μg kg-1) over 5-10 minutes ,dexmedetomidine(precedex 200 micrograms per 2ml, Abbott laboratories, Abbott park, IL, USA), the dexmedetomidine calculated dose was withdrawn then completed with saline in 20 ml syringe followed by ketamine 0.5 mg/kg IV infused slowly over 5-10 minutes (Ketalar, 50 mg/ml, 10 ml; Pfizer, Sandwich, UK) where the calculated dose was withdrawn then diluted with saline in 20 ml syringe before intervention. 5-10 minutes,A rescue dose of Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was given at 2-min intervals in case of inadequate sedation (sedation score<5). intravenous (IV) dexmedetomidine (1 μg kg-1) over 5-10 minutes diluted in 20ml saline in addition to 0.5 mg/kg IV infused slowly over 5-10 minutes diluted in 20 ml saline 20
Control Group ketamine midazolam intravenous bolus dose of midazolam 0.05 mg/kg over 5-10 minutes (Dormicum, 1mg/ml, 5ml;Deva Holding, Istanbul) the calculated dose was diluted in normal saline in 20 ml syringe followed by a bolus dose of ketamine 0.5mg/kg administered IV slowly over 5-10 minutes (Ketalar, 50 mg/ml, 10 ml; Pfizer, Sandwich, UK) it was adjusted in the same way over 5-10 minutes, A rescue dose of Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was given over 2-min intervals in case of inadequate sedation (sedation score<5). intravenous bolus dose of midazolam 0.05 mg/kg over 5-10 minutes diluted in 20 ml saline, in addition to a bolus dose of ketamine 0.5mg/kg administered IV slowly over 5-10 minutes diluted in 20 ml saline 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
paediatric patients 2-3 years old, (ASA) physical status III with surgically uncorrected TOF scheduled for multi-slice spiral computed tomography active chest infection, renal impairement, parent refusal to participate hypersensitivity to study drugs any contraindication to the study drugs were excluded. Preschool Child: 2 Year-5 Year 2 Year(s) 3 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/03/2018 faculty of medicine ain shams university
Ethics Committee Address
Street address City Postal code Country
Ramsis street cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the recovery time for all patients (The elapsed time for the participant to open his eyes upon command after discontinuation of the study drug). at the end of the procedure
Secondary Outcome sedation scores at baseline, 3,6,9 minutes after study mixture administration
Secondary Outcome systolic and diastolic blood pressures at baseline, 3,6,9 minutes after study mixture administration,
Secondary Outcome postoperative complications at the end of the procedure and in the recovery
Secondary Outcome additional doses of ketamine during the procedure about 10 minutes
Secondary Outcome intraoperative complications as hypoxia during the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
operating rooms of ain shams university hospitals abbasya square, Ramsis street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hoda shokri Ramsis street CAIRO cairo 9676 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hoda shokri Abbasya square Ramsis street Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amr kasem Abbasya square Ramsis street cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hoda shokri drhoda10@yahoo.com 00201211179234 Ramsis street
City Postal code Country Position/Affiliation
cairo Egypt Associate professor of Anesthesiology
Role Name Email Phone Street address
Public Enquiries Amr kasem amr240@gmail.com 00201005282224 Ramsis street
City Postal code Country Position/Affiliation
cairo Egypt lecturer of Anesthesiology
Role Name Email Phone Street address
Scientific Enquiries reem elkabarity rhelkabarity@yahoo.co.uk 00201144498371 Ramsis street
City Postal code Country Position/Affiliation
cairo Egypt professor of anaesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes randomised prospective clinical trial Statistical Analysis Plan,Study Protocol 6 months dexmedetomidine- TOF- Midazolam- paediatrics
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information